SOM Compliance Trends and the Benefits of Software Analytics

In accordance with Drug Enforcement Administration (DEA) rules, drug manufacturers and distributors are mandated to design and implement a system that identifies suspicious ordering activity of controlled substances known as a Suspicious Order Monitoring (SOM) program. Industry members want to comply, but are unaware of the trends that they should be aware of in order to achieve and maintain compliance. Many manufacturers and distributors don’t know how to initiate the process of establishing an SOM program, while others make the risky presumption that their system is proficient as is. Even major players in the pharmaceutical industry are susceptible to this pitfall, with many being penalized for excessive shipment of abuse-prone prescriptions drugs.

In accordance with Drug Enforcement Administration (DEA) rules, drug manufacturers and distributors are mandated to design and implement a system that identifies suspicious ordering activity of controlled substances known as a Suspicious Order Monitoring (SOM) program. Industry members want to comply, but are unaware of the trends that they should be aware of in order to achieve and maintain compliance. Many manufacturers and distributors don’t know how to initiate the process of establishing an SOM program, while others make the risky presumption that their system is proficient as is. Even major players in the pharmaceutical industry are susceptible to this pitfall, with many being penalized for excessive shipment of abuse-prone prescriptions drugs.

FDA's newly passed UDI rule has had a major impact on the medical device industry. Our experts will present on best practices for compliance with the UDI rule, including an easy-to-understand interpretation of the required compliance timelines for each class of device, a review of the individual components that make up the UDI, as well as guidance on the available labeling standards (GS1, HIBCC, ISBT 128). . Ideal participants include medical device quality and compliance executives, I.T. decision makers, and anyone else for whom the Unique Device Identification rule is a concern. The event is being presented by QDevice, the medical device division of QPharma, a leading regulatory compliance consulting firm.